MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number 69210

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018, as no exact event date was reported.User facility reference number: (b)(4).(b)(4).Captures the reportable event of probe broke.Visual examination of the returned ultrasound probe revealed that it was broken about 10cm from the head.Therefore, a review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a lithoclast 3.8mm x 403mm ultrasound disposable probe was used in a procedure performed on (b)(6)2018.According to the complainant, during the procedure, the ultrasound probe got busted.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.Note: this event has been deemed an mdr-reportable event based on investigation results, which revealed that the ultrasound probe was broken and because of the ambiguity of where the fragments detached.Please refer to block h10 for full investigation details.

• Brand Name: ULTRASOUND PROBE
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ELECTRO MEDICAL SYSTEMS SA; ch. de la vuarpillière 31; ch-1260,; nyon, sz 1260 ; CH 1260
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8130471
• MDR Text Key: 129333791
• Report Number: 3005099803-2018-61642
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: 08714729516613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 69210
• Device Catalogue Number: 69210
• Device Lot Number: 0022240371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 76